Supplementary funding to support the extension of the EDCTP-funded PrEPVacc trial
Lead Research Organisation:
Imperial College London
Department Name: UNLISTED
Abstract
"Supplementary funding to support the extension of the EDCTP-funded trial ""A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEPVacc)"" held by Professor Jonathan Weber (Imperial College of Science Technology and Medicine, UK). PrEPVacc is a Phase IIb, three-arm, two-stage HIV efficacy vaccine trial with a second randomisation to compare the newer PrEP drug Descovy to the established standard for PrEP, Truvada (https://www.prepvacc.org/)
The supplementary funding will allow follow-up of trial participants and complete analysis of the trial data. "
The supplementary funding will allow follow-up of trial participants and complete analysis of the trial data. "
Technical Summary
"Supplementary funding to support the extension of the EDCTP-funded trial ""A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEPVacc)"" held by Professor Jonathan Weber (Imperial College of Science Technology and Medicine, UK). PrEPVacc is a Phase IIb, three-arm, two-stage HIV efficacy vaccine trial with a second randomisation to compare the newer PrEP drug Descovy to the established standard for PrEP, Truvada (https://www.prepvacc.org/)
The supplementary funding will allow follow-up of trial participants and complete analysis of the trial data. "
The supplementary funding will allow follow-up of trial participants and complete analysis of the trial data. "
Organisations
- Imperial College London (Lead Research Organisation)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- International AIDS Vaccine Initiative (IAVI) (Collaboration)
- Instituto Nacional de Saúde (Collaboration)
- University College London (Collaboration)
- Karolinska Institute (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- Lausanne University Hospital (CHUV) (Collaboration)
- National Institute for Medical Research, Tanzania (Collaboration)
- Eastern Virginia Medical School (Collaboration)
- Ludwig Maximilian University of Munich (LMU Munich) (Collaboration)
- MRC/UVRI Uganda Research Unit on AIDS (Collaboration)
- Eurovacc Foundation (Collaboration)
People |
ORCID iD |
Publications
Kansiime S
(2023)
Developing HIV risk prediction tools in four African settings
in Tropical Medicine & International Health
| Description | PrEPVacc PrEP Dosing Advice Project |
| Geographic Reach | Africa |
| Policy Influence Type | Contribution to new or improved professional practice |
| Description | Additional funding for PrEPVacc |
| Amount | € 1,624,582 (EUR) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 12/2024 |
| Description | PrEPVacc shortfall funding |
| Amount | € 1,000,000 (EUR) |
| Organisation | German Federal Ministry of Education and Research |
| Sector | Public |
| Country | Germany |
| Start | 01/2022 |
| End | 12/2022 |
| Description | PrEPVacc |
| Organisation | Eastern Virginia Medical School |
| Country | United States |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Eurovacc Foundation |
| Country | Switzerland |
| Sector | Charity/Non Profit |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Instituto Nacional de Saúde |
| Country | Mozambique |
| Sector | Public |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | International AIDS Vaccine Initiative (IAVI) |
| Country | Global |
| Sector | Charity/Non Profit |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Karolinska Institute |
| Country | Sweden |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Lausanne University Hospital (CHUV) |
| Country | Switzerland |
| Sector | Hospitals |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Ludwig Maximilian University of Munich (LMU Munich) |
| Country | Germany |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | MRC/UVRI Uganda Research Unit on AIDS |
| Country | Uganda |
| Sector | Public |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Medical Research Council of South Africa (MRC) |
| Country | South Africa |
| Sector | Public |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | Muhimbili University of Health and Allied Sciences |
| Country | Tanzania, United Republic of |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | National Institute for Medical Research, Tanzania |
| Department | NIMR Mbeya Research Centre |
| Country | Tanzania, United Republic of |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Description | PrEPVacc |
| Organisation | University College London |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | PrEPVacc is a combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Eurovacc Foundation, Imperial, LMU, KI and MRC/CTU at UCL. The clinical centres will be based at MUHAS; Dar es Salaam, NIMR Mbeya; Mbeya, MRC-SA; Durban, MRC/UVRI; Masaka Imperial is the co-ordinator of the project and vaccine product provider (MVA-CMDR, CN54gp140, MPLA-L) |
| Collaborator Contribution | MRC/CTU at UCL support the clinical co-ordination of the trial LMU and KI contribute to lab capacity building IAVI provide the monitoring activities for the trial EVF and CHUV have provided one of the vaccines DNA-HIV-PT-123 for the trial East Virginia Medical School have provided urine tenofovir kits to analysis PrEP uptake and adherence |
| Impact | The clinical study is still running. |
| Start Year | 2018 |
| Title | PrEPVacc clinical trial |
| Description | PrEPVacc is an international, multicentre, double-blind vaccine study will be a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control. The study is funded by EDCTP. Pre-screening for risk and HIV status will take place as part of a Registration Cohort which will precede and continue in parallel to PrEPVacc enrolments. This will give HIV negative volunteers time to learn about the PrEPVacc trial and facilitate timely enrolment. Clinical screening for the vaccine trial will take place during the 8 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to one of three vaccine arms: ? DNA-HIV-PT123 and AIDSVAX® B/E (target wks 0,4,24,48) ? DNA-HIV-PT123 and CN54gp140+MPLA-L (target wks 0,4), then MVA-CMDR and CN54gp140+MPLA-L (target wks 24,48) ? Saline placebo (target wks 0,4,24,48 There will be a concurrent 1:1 randomisation comparing two PrEP regimens, open-label: ? Daily TDF/FTC ? Daily TAF/FTC Participants will continue to receive study PrEP through to 2 weeks after their third immunisation after which access to PrEP will revert to locally registered supply of generic drug. The trial is currently enrolling at 4 clinical centres, 2 in Tanzania, 1 in South Africa and 1 in Uganda. To date the trial has enrolled 543 out of 1668 participants |
| Type | Preventative Intervention - Physical/Biological risk modification |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2017 |
| Development Status | Closed |
| Clinical Trial? | Yes |
| UKCRN/ISCTN Identifier | NCT04066881 |
| Impact | Trial has finished vaccinations and is exiting participants. No notable impacts |
| Description | Media cafe |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Policymakers/politicians |
| Results and Impact | AVAC Media Café - Speakers Eugene Ruzagira (UVRI), Sheila Kansiime (UVRI) provided the briefing and Xoliswa Nomvungu, SAMRC CWG member shared her opinions and response to the study update Link to the AVAC media café recording and password: Link: https://us06web.zoom.us/rec/share/0X_mfb7ueHLEM0pIxCk4zxT3i3PpmYJ6JQlk5ZdGLZxuRe2-RcNKhIsfYz2d2sfI.4pMTs4RuCdsG3YrF Passcode: oRa#.=y1 |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://us06web.zoom.us/rec/share/0X_mfb7ueHLEM0pIxCk4zxT3i3PpmYJ6JQlk5ZdGLZxuRe2-RcNKhIsfYz2d2sfI.4... |
| Description | New article by CNN international |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | A trial is underway that could be 'the last roll of the dice' for an HIV vaccine this decade https://edition.cnn.com/2023/08/28/health/prepvacc-hiv-vaccine-trial-spc-scn-intl/index.html The article by Tom Page resulted from a series of interviews with Jonathan Weber, Eugene Ruzagira, Nishanta Singh and Neetha Morar from the PrEPVacc trial |
| Year(s) Of Engagement Activity | 2023 |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | News article on HIV vaccines https://www.prepvacc.org/news/stat-can-the-world-still-invent-an-hiv-vaccine-progress-in-one-area-creates-new-problem |
| Year(s) Of Engagement Activity | 2023 |
| Description | News release |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | News Release: African-led PrEPVacc HIV prevention study completes its enrolment https://www.prepvacc.org/news/news-release-african-led-prepvacc-hiv-prevention-study-completes-its-enrolment |
| Year(s) Of Engagement Activity | 2023 |
| Description | Workshop for Uganda Youth Organisations |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Schools |
| Results and Impact | In partnership with trial host communities, we commemorated World HIV Vaccine Awareness Day (18th May) and World AIDS Day (1st December 2023). Engaged communities, mostly the youth, MARPs in HIV prevention discussions, supplied condoms, offered HCT and referral for counselling and PrEP |
| Year(s) Of Engagement Activity | 2023 |
| Description | webinar |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | AVAC webinar - Approximately 170 attendees from around the world. Speakers Sheena Mc Cormack (UCL), Eugene Ruzagira (UVRI) Sheila Kansiime (UVRI) and Rachel Kawuma (UVRI) Community Opinion by Verulam CWG member Xoliswa Nomvungu discussed the PrEPVacc trial. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://avac.org/event/prepvacc-an-in-depth-look-at-the-trial-and-whats-next/ |